Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration

Completed

• Conditions: Age Related Macular Degeneration

• Registration Number: NCT03035461
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".

Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.

After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.

The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-03-15
• Primary Completion: 2018-02-01
• Study Completion: 2018-10-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• patient up to 55 years old
• wet AMD
• diagnostic questionnaire group: patient being announced with AMD for less than 1 month
• disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months

Exclusion Criteria

• dry AMD
• patient under 55 years old
• patient who doesn't speak French
• patient carrying an ophtalmologic genetic disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the patient's feelings	up to 1 month after diagnosis	A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.

Secondary Outcome Measures

Name	Time	Method
score of satisfaction of announcement conditions	between 6 months and 1 year of follow-up
score on a comprehension quiz on AMD	up to 1 month after diagnosis
Score on the anxiety PHQ9 questionnaire	between 6 months and 1 year of follow-up
score of general satisfaction	up to 1 month after diagnosis	the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)
Score on a composite score evaluating the clarity of medical explanations	between 6 months and 1 year of follow-up
score of satisfactions regarding the clarity of the disease course and treatment explanations	between 6 months and 1 year of follow-up
Score on the anxiety GAD7 questionnaire	between 6 months and 1 year of follow-up

Trial Locations

Locations (1)

Marciano Joelle; 🇫🇷 Créteil, Creteil, France